§316.28. Publication of orphan-drug designations.
21 C.F.R. § 316.28
Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information:
The name and address of the sponsor;
The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;
The date of the granting of orphan-drug designation;
The designated use in the rare disease or condition; and
If the drug loses designation after August 12, 2013, the date of it no longer having designation.
Notes, amendments, and revision history
Amendments
[78 FR 35134, June 12, 2013]
Authority
Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
Source
Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.
Amendments
[78 FR 35134, June 12, 2013]